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Trial record 4 of 29 for:    "Nerve Compression Syndrome" | "Anti-Inflammatory Agents"

Lipografting Versus Steroid Injections for Treatment of Carpal Tunnel Syndrome

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ClinicalTrials.gov Identifier: NCT03722303
Recruitment Status : Recruiting
First Posted : October 26, 2018
Last Update Posted : October 29, 2018
Sponsor:
Collaborator:
Orthopaedic Scientific Research Foundation
Information provided by (Responsible Party):
Melvin Rosenwasser, Columbia University

Brief Summary:
This study applies the regenerative properties of autologous fat transfer to treat mild to moderate carpal tunnel syndrome in comparison to the current standard of care, corticosteroid treatment. The investigators hypothesize the fat transfer would prevent scar formation and aid in nerve excursion along the canal (while the neoangiogenic and regenerative growth factors could stimulate nerve regeneration) better than the standard of care treatment.

Condition or disease Intervention/treatment Phase
Carpal Tunnel Syndrome Other: Fat Injection Drug: Steroid Injection Early Phase 1

Detailed Description:

Carpal tunnel syndrome (CTS) is the most common entrapment neuropathy affecting up to 13% of Americans; CTS is caused by compression of the median nerve in the carpal tunnel leading to nerve ischemia and symptoms of numbness, pain, and tingling. Treatment options depend on the severity of symptoms and range from noninvasive options (most commonly, steroid injections) to definitive surgical release of the compressed median nerve. Both non-invasive techniques and surgical intervention have their shortcomings; thus a novel approach for CTS treatment may be indicated.

Lipografting is an established, validated, and widely used technique of plastic surgeons that injects autologous fat to correct contour deformities. From observing these reconstructions, plastic surgeons have witnessed the regenerative properties of fat transfer, specifically delaying the affects of chronic radio-dermatitis. These clinical manifestations have fostered numerous studies defining fat as a rich source of pluripotent stem cells with the potential for reducing scar formation, bringing neo-angiogenesis, and providing a barrier against scar adhesions This study applies the regenerative properties of autologous fat transfer to treat mild to moderate carpal tunnel syndrome in comparison to the current standard of care, corticosteroid treatment. Ideally, the fat transfer would prevent scar formation and aid in nerve excursion along the canal, while the neoangiogenic and regenerative growth factors could stimulate nerve regeneration.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Lipografting Versus Steroid Injections for Treatment of Primary Mild to Moderate Carpal Tunnel Syndrome
Actual Study Start Date : December 19, 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019


Arm Intervention/treatment
Active Comparator: Steroid Injection
Subjects with CTS will receive steroid injection.
Drug: Steroid Injection
Standard of care non-operative treatment for the treatment of Carpal Tunnel Syndrome
Other Name: Cortisone Injection

Experimental: Fat Injection
Subjects with CTS will receive fat injection.
Other: Fat Injection
Used by plastic surgeons, lipografting injects autologous fat to correct contour deformities. Plastic surgeons have witnessed the regenerative properties of fat transfer, and these clinical manifestations have fostered numerous studies defining fat as a rich source of pluripotent stem cells with the potential for reducing scar formation, bringing neo-angiogenesis, and providing a barrier against scar adhesions. This study applies the regenerative properties of autologous fat transfer to treat mild to moderate carpal tunnel syndrome in comparison to the current standard of care, corticosteroid treatment. Ideally, fat transfer would prevent scar formation and aid in nerve excursion along the canal, while the neoangiogenic and regenerative growth factors stimulate nerve regeneration.
Other Name: Fat Transfer




Primary Outcome Measures :
  1. Functional Outcome Score [ Time Frame: Up to 1 year post-treatment ]
    This score will be determined by Quick-Disabilities of the Arm, Shoulder and Hand (QuickDASH), which is a validated tool/survey for measuring upper extremity disability. The QuickDASH is scored in two components: the disability/symptom section (11 items, scored 1-5) and the optional high performance sport/music or work modules (4 items, scored 1-5). These raw scores are used to calculate a score out of 100, with a higher score indicating greater disability.


Secondary Outcome Measures :
  1. Score on the Michigan Hand Questionnaire (MHQ) [ Time Frame: Up to 1 year post-treatment ]
    The MHQ is hand-specific outcomes instrument that measures outcomes of patients with conditions of, or injury to, the hand or wrist. In the pain scale, high scores indicate greater pain, while in the other five scales, high scores denote better hand performance.

  2. Score on the Brigham Women's Carpal Tunnel Questionnaire [ Time Frame: Up to 1 year post-treatment ]
    Brigham Women's Carpal Tunnel Questionnaire is a validated tool for measuring severity of symptoms for carpal tunnel syndrome. The questionnaire is self-administered, with each item scored from 1 to 5 (where 1 indicates no symptoms or no functional difficulty, and 5 indicates maximum symptoms or an inability to perform the functional task).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • primary mild to moderate carpal tunnel syndrome (CTS)
  • report symptoms longer than 6 months
  • night pain
  • weakness
  • sensory deficits
  • fluent English-speaking adult (>18)

Exclusion Criteria:

  • <18 years old
  • Non-english speaking
  • injection in past 6 months
  • previous hand surgery
  • previous hand trauma (fracture or dislocation)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03722303


Contacts
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Contact: Christina Freibott (212) 305-3912 cef2141@cumc.columbia.edu

Locations
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United States, New York
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Contact: Christina Freibott    212-305-3912    cef2141@cumc.columbia.edu   
Principal Investigator: Melvin P Rosenwasser, MD         
Sponsors and Collaborators
Columbia University
Orthopaedic Scientific Research Foundation
Investigators
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Principal Investigator: Melvin P Rosenwasser, MD Department of Orthopaedic Surgery at Columbia University Medical Center

Publications:
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Responsible Party: Melvin Rosenwasser, Robert E. Carroll Professor of Hand Surgery, Columbia University Medical Center Attending Physician, Director of the Trauma Training Center, Director of Hand Fellowship, Columbia University
ClinicalTrials.gov Identifier: NCT03722303     History of Changes
Other Study ID Numbers: AAAK4700
First Posted: October 26, 2018    Key Record Dates
Last Update Posted: October 29, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Melvin Rosenwasser, Columbia University:
carpal
tunnel
injection
steroid
lipografting
numbness
tingling
median nerve
Additional relevant MeSH terms:
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Nerve Compression Syndromes
Anti-Inflammatory Agents
Carpal Tunnel Syndrome
Syndrome
Disease
Pathologic Processes
Median Neuropathy
Mononeuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Cumulative Trauma Disorders
Sprains and Strains
Wounds and Injuries
Cortisone